BEUDAMED
    FDA Adverse Event Other Summary report: N

    COAPTITE

    MDR report key: 770331 · Received October 13, 2006

    Report

    Report Number
    2135225-2006-00016
    Event Type
    Other
    Date Received
    October 13, 2006
    Date of Event
    July 12, 2006
    Report Date
    October 12, 2006
    Manufacturer
    BIOFORM MEDICAL, INC.
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FOLLOW-UP WITH THE PHYSICIAN, IT WAS REPORTED THAT THE URINARY RETENTION SYMPTOMS HAD RESOLVE. DR. STATED THAT, SHE HAD TREATED THE PATIENT FOR RETENTION, BUT WAS NOT THE INJECTING PHYSICIAN. THE ACTUAL COAPTITE LOT WAS UNKNOWN; HOWEVER, BASED ON THE CUSTOMER ORDER HISTORY, THERE ARE 2 POSSIBLE LOT NUMBERS. A REVIEW OF THE DEVICE HISTORY RECORDS FOR BOTH COAPTITE LOTS INDICATES THAT 1002346 AND 1002378 MET SPECIFICATIONS AT THE TIME OF RELEASE. THIS EVENT WAS NOT INITIALLY REPORTED AS A SERIOUS INJURY. UPON REVIEW OF THE REGULATIONS, IT WAS NOTED THAT THIS EVENT SHOULD BE REPORTED. BIOFORMM UNDERSTANDS THAT THIS INITIAL REPORT IS BEYOND THE 30-DAY TIME FRAME.

    Description of Event or Problem · 1

    DR. REPORTED THAT, A PATIENT WAS INJECTED WITH COAPTITE, FOR A URETHRAL BULKING PROCEDURE IN 2006. THIS PATIENT HAS BEEN IN URINARY RETENTION SINCE THE DATE OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT LMH BIOFORM MEDICAL, INC. * 1002346

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention